US6488956B1 - Multi-vitamin and mineral supplements for women - Google Patents
Multi-vitamin and mineral supplements for women Download PDFInfo
- Publication number
- US6488956B1 US6488956B1 US09/448,744 US44874499A US6488956B1 US 6488956 B1 US6488956 B1 US 6488956B1 US 44874499 A US44874499 A US 44874499A US 6488956 B1 US6488956 B1 US 6488956B1
- Authority
- US
- United States
- Prior art keywords
- vitamin
- total daily
- daily dosage
- mineral
- women
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Fee Related
Links
- 229940029985 mineral supplement Drugs 0.000 title claims abstract description 46
- 235000020786 mineral supplement Nutrition 0.000 title claims abstract description 46
- 235000020772 multivitamin supplement Nutrition 0.000 title claims abstract description 42
- 229940088594 vitamin Drugs 0.000 claims abstract description 56
- 239000011782 vitamin Substances 0.000 claims abstract description 56
- 239000011707 mineral Substances 0.000 claims abstract description 51
- 229910052500 inorganic mineral Inorganic materials 0.000 claims abstract description 50
- 229930003231 vitamin Natural products 0.000 claims abstract description 49
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- AUNGANRZJHBGPY-SCRDCRAPSA-N Riboflavin Chemical compound OC[C@@H](O)[C@@H](O)[C@@H](O)CN1C=2C=C(C)C(C)=CC=2N=C2C1=NC(=O)NC2=O AUNGANRZJHBGPY-SCRDCRAPSA-N 0.000 claims description 17
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- PVNIIMVLHYAWGP-UHFFFAOYSA-N Niacin Chemical compound OC(=O)C1=CC=CN=C1 PVNIIMVLHYAWGP-UHFFFAOYSA-N 0.000 claims description 15
- FDJOLVPMNUYSCM-WZHZPDAFSA-L cobalt(3+);[(2r,3s,4r,5s)-5-(5,6-dimethylbenzimidazol-1-yl)-4-hydroxy-2-(hydroxymethyl)oxolan-3-yl] [(2r)-1-[3-[(1r,2r,3r,4z,7s,9z,12s,13s,14z,17s,18s,19r)-2,13,18-tris(2-amino-2-oxoethyl)-7,12,17-tris(3-amino-3-oxopropyl)-3,5,8,8,13,15,18,19-octamethyl-2 Chemical compound [Co+3].N#[C-].N([C@@H]([C@]1(C)[N-]\C([C@H]([C@@]1(CC(N)=O)C)CCC(N)=O)=C(\C)/C1=N/C([C@H]([C@@]1(CC(N)=O)C)CCC(N)=O)=C\C1=N\C([C@H](C1(C)C)CCC(N)=O)=C/1C)[C@@H]2CC(N)=O)=C\1[C@]2(C)CCC(=O)NC[C@@H](C)OP([O-])(=O)O[C@H]1[C@@H](O)[C@@H](N2C3=CC(C)=C(C)C=C3N=C2)O[C@@H]1CO FDJOLVPMNUYSCM-WZHZPDAFSA-L 0.000 claims description 15
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- QYSXJUFSXHHAJI-XFEUOLMDSA-N Vitamin D3 Natural products C1(/[C@@H]2CC[C@@H]([C@]2(CCC1)C)[C@H](C)CCCC(C)C)=C/C=C1\C[C@@H](O)CCC1=C QYSXJUFSXHHAJI-XFEUOLMDSA-N 0.000 description 11
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- 229960002477 riboflavin Drugs 0.000 description 7
- 229960003495 thiamine Drugs 0.000 description 7
- KYMBYSLLVAOCFI-UHFFFAOYSA-N thiamine Chemical compound CC1=C(CCO)SCN1CC1=CN=C(C)N=C1N KYMBYSLLVAOCFI-UHFFFAOYSA-N 0.000 description 7
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
- A23L33/15—Vitamins
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
- A23L33/16—Inorganic salts, minerals or trace elements
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
- A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
Definitions
- the present invention relates to multi-vitamin and mineral supplements, and particularly to multi-vitamin and mineral supplements for administration to women.
- the go supplements are specifically tailored to meet nutritional requirements and maintain a woman s health during specific stages of life.
- the present invention also relates to methods of optimizing the health of women by providing multi-vitamin and mineral supplements which are specifically tailored to achieve optimal regulation of growth, maintenance and repair of body tissue during specific stages of life with minimal side effects. Methods of formulating multi-vitamin and mineral supplements for life stages are also encompassed by the present invention.
- Vitamin and mineral preparations are commonly administered to treat specific medical conditions or as general nutritional supplements. Recent studies have elucidated the important physiological roles played by vitamins and minerals, and established a correlation between deficiencies or excesses of these nutrients and the etiologies of certain disease states in humans. See, e.g., Diplock, “Antioxidant Nutrients and Disease Prevention: An Overview,” Am. J. Clin. Nutr., 53:189-193 (1991); Document Geigy Scientific Tables, 457-497 (Diem and Cemtuer eds., 7th ed., 1975).
- U.S. Pat. No. 4,994,283 discloses nutritional mineral supplements which include iron and calcium compounds in combination with citrates or tartrates, ascorbates, and fructose.
- the tendency of calcium to inhibit the bioavailability of iron is said to be reduced in such compositions, so that the conjoint bioavailability of these two minerals is enhanced.
- U.S. Pat. No. 4,431,634 discloses maximization of iron bioavailability in prenatal iron supplements by maintaining the amount of calcium compounds in the supplement at 300 mg or less and the amount of magnesium compounds at 75 mg or less per dosage unit.
- a multi-vitamin and mineral dietary supplement which includes (a) one or more divalent dietary mineral components such as calcium or magnesium; and (b) a bioavailable iron component, presenting a controlled release form and adapted to be released in a controlled manner in the gastrointestinal tract.
- U.S. Pat. No. 4,710,387 discloses a nutritional supplement preparation for pregnant and breast-feeding women which contains 10-20% by weight of protein, 16-28% by weight of fat, 43-65% by weight carbohydrates, and at most 3.5% by weight of moisture, minerals, trace elements and vitamins.
- Multi-vitamin and mineral formulations which are directed specifically to woman have been disclosed in prior patents and in the medical literature.
- the Physicians' Desk Reference (PDR) for Nonprescription Drugs, 9th Edition, 718-19 (1988) discloses a complete calcium/vitamin/mineral supplement program formulated for women.
- the program contains two specific formulas. One formulation is directed to woman between the ages of 14 and 40, and the other formulation is directed to woman over the age of 40. These formulations do not specifically distinguish between the varying physiological states experienced by women throughout the course of their lives. In fact, by providing one formulation for the broad category of woman aged 14-40, this disclosure highlights the need for more specific formulations.
- WO 95/35098 discloses multi-vitamin and mineral supplements for administration to lactating, non-lactating, and menopausal women which comprise specific regimens of critical nutritional agents. This reference teaches formulations containing high amounts of iron, zinc and vitamin B 12 , and low amounts of vitamin B 12 and vitamin B 6 .
- the present invention overcomes the shortcomings of known nutritional supplements by providing multivitamin and mineral supplements which are specifically tailored for administration to woman during various stages of life, and more specifically to lactating, non-lactating, and menopausal women.
- the formulations of the invention have been found to maximize the benefits of vitamin and mineral supplementation for women by specifically formulating the products to meet the physiological requirements of women during these life stages.
- each vitamin and mineral in a multi-vitamin formulation is affected by the presence of other vitamins and minerals in the formulation, as well as by the amounts of each vitamin and mineral present and the physiological state of the individual using said formulation.
- Use of the specific formulations of the present invention for the prescribed life stages unexpectedly results in a higher bioavailability of essential nutrients.
- compositions of the invention include certain essential nutritional components in dosage levels which have been found to optimize the maintenance of a woman's health during each of the noted stages of life.
- Minerals such as calcium, zinc and iron are dosed (i.e. provided in the supplement) in the form of a corresponding pharmaceutically acceptable compound.
- a multi-vitamin and mineral supplement for administration to a lactating woman is provided.
- This supplement is specially designed to aid in fulfilling the dietary needs of women who are producing and secreting milk, that is, lactating women.
- the multi-vitamin and mineral supplement comprises:
- a multi-vitamin and mineral supplement for administration to a non-lactating woman is also provided by the invention.
- This supplement is designed to aid in fulfilling the dietary needs of women during the period after puberty and before menopause who are neither pregnant nor lactating.
- This formulation comprises:
- (k) a total daily dosage of about 12 mg to about 30 mg of elemental zinc dosed in the form of a pharmaceutically acceptable zinc compound.
- a multi-vitamin and mineral supplement for administration to a menopausal woman is also provided.
- This supplement is specially designed to aid in fulfilling the dietary needs of women during the transitional period marked by the cessation of menses.
- Menopausal women may be asymptomatic or experience a variety of symptoms including hot flushes. See The Merck Manual of Diagnosis and Therapy 15th edition, 1713-1715. Most menopausal women experience hot flushes for over a year and 25 to 50% experience hot flushes for more than five years.
- the supplement for menopausal women of the present invention comprises:
- a method for optimizing the health of a woman comprises administering to said woman a multi-vitamin and mineral supplement comprising vitamins and minerals in amounts adjusted according to varying physiological conditions of said woman over a lifetime.
- a method for formulating a multi-vitamin and mineral supplement which optimizes the health of a woman comprises:
- step (d) preparing a multi-vitamin and mineral supplement containing the determined optimal amounts of each vitamin and mineral of step (c).
- the invention provides the above-described multi-vitamin and mineral supplements for administration to lactating, non-lactating, and menopausal women, as well as methods both for optimizing the health of women and for preparing formulations for same.
- the formulations of the invention comprise specific regimens of critical nutritional agents, in order to better meet the physiological requirements of women and maintain good health throughout life.
- non-lactating woman refers to a woman who has experienced puberty, but has not experienced menopause, and who is not lactating and not pregnant.
- Nutrient refers to any substance in a human or other living organism which regulates the growth, maintenance, and repair of body tissue, as well as any substance which provides energy or structural material to the body.
- Essential nutrient refers to any nutrient which is not produced by a human or other living organism and thus must be obtained from an external source.
- Body tissue refers to any substance in a human or other living organism which is composed of the cells of said human or other organism, respectively.
- Total daily dosage refers to the amount of any nutrient formulated for administration during any 24 hour period of time.
- AM dose refers to any dose of a multi-vitamin and mineral supplement formulated for administration in the morning hours
- PM dose refers to any dose of a multi-vitamin and mineral supplement formulated for administration in the afternoon, evening or nighttime hours.
- Life stage refers to a specific period of time during the course of an individual's life.
- the invention provides multi-vitamin and mineral supplements which are tailored for women at different life stages, and specifically for administration to lactating, non-lactating, and menopausal women.
- the formulations of the invention include certain essential nutritional components in dosage levels which have been found to optimize the maintenance of a woman's health during each of these stages of life.
- a multi-vitamin and mineral supplement for administration to a lactating woman which comprises:
- a particularly preferred multi-vitamin and mineral supplement for lactating women also includes from about 160 mg to about 240 mg of a pharmaceutically acceptable magnesium compound and about 95 mg to about 145 mg of vitamin C.
- a multi-vitamin and mineral supplement for administration to a non-lactating woman is also provided by the invention.
- This supplement is designed to specifically aid in fulfilling the dietary needs of women during the period after puberty and before menopause who are neither pregnant nor lactating.
- the invention may be used by a non-lactating woman who has never given birth or a non-lactating woman who has given birth one or more times.
- the formulation comprises:
- (k) a total daily dosage of about 12 mg to about 30 mg of elemental zinc dosed in the form of a pharmaceutically acceptable zinc compound.
- the multi-vitamin and mineral supplement for non-lactating women also includes from about 160 mg to about 240 mg of a pharmaceutically acceptable magnesium compound and about 95 mg to about 300 mg of vitamin C, or more preferably from about 180 mg to about 220 mg of a pharmaceutically acceptable magnesium compound, from about 180 to about 220 mg of vitamin C, from about 0.040 mg to about 0.060 mg of a pharmaceutically acceptable molybdenum compound, and from about 0.080 mg to about 0.120 mg of a pharmaceutically acceptable chromium compound.
- the present invention includes a multi-vitamin and mineral supplement for administration to a non-lactating woman which comprises:
- (k) a total daily dosage of about 14 mg to about 25 mg of elemental zinc dosed in the form of a pharmaceutically acceptable zinc compound.
- the present invention includes a multi-vitamin and mineral supplement for administration to a non-lactating woman which comprises:
- (k) a total daily dosage of about 14 mg to about 25 mg of elemental zinc dosed in the form of a pharmaceutically acceptable zinc compound.
- a multi-vitamin and mineral supplement for administration to a menopausal woman which comprises:
- a particularly preferred multi-vitamin and mineral supplement for menopausal women also includes about 160 mg to about 240 mg of a pharmaceutically acceptable magnesium compound.
- a method for optimizing the health of a woman comprises administering to said woman a multi-vitamin and mineral supplement comprising vitamins and minerals in amounts adjusted according to varying physiological conditions of said woman over a lifetime.
- the method comprises administering to said non-lactating woman a multi-vitamin and mineral supplement comprising:
- (k) a total daily dosage of about 12 mg to about 30 mg of elemental zinc dosed in the form of a pharmaceutically acceptable zinc compound.
- a method for formulating a multi-vitamin and mineral supplement which optimizes the health of a woman is also included. This method comprises:
- step (d) preparing a multi-vitamin and mineral supplement containing the determined optimal amounts of each vitamin and mineral of step (c).
- the formulations vary in the critical nutritional agents included and amounts thereof.
- levels of calcium are higher for administration to lactating women than in the non-lactating and menopausal formulations.
- the amount of iron in the menopausal formulation is reduced greatly in comparison to the formulations for lactating and non-lactating women.
- Molybdenum and chromium are added to the menopausal formulation because these agents are believed to assist the immune system, which is a useful therapy in older women.
- the present invention addresses the problem of providing optimal supplementation of vitamins and minerals while eliminating or at least minimizing said side effects. Accordingly, the present invention is designed to minimize adverse effects often experienced by women when taking vitamin and mineral supplements while providing the optimal amount of vitamins and minerals.
- the present invention is contemplated for use by women of varying physical conditions, without limitation, including normal, healthy women and women with a physical disorder, vitamin or mineral deficiency, or a nutritional disorder.
- Non-limiting exemplary vitamin deficiencies include vitamin A deficiency, hypervitaminosis A, vitamin D deficiency and dependency, hypervitaminosis D, vitamin E deficiency and toxicity, vitamin K deficiency, hypervitaminosis K, essential fatty acid deficiency, thiamine deficiency, riboflavin deficiency, niacin deficiency, vitamin B 6 deficiency and dependency, biotin deficiency and dependancy, pantothenic acid deficiency, carnitine deficiency and vitamin C deficiency.
- Non-limiting exemplary mineral deficiencies include phosphate depletion, iodine deficiency, fluorine deficiency, zinc deficiency disturbances in copper metabolism, acquired copper deficiency, acquired copper toxicosis, inherited copper deficiency and inherited copper toxicosis.
- Useful pharmaceutically acceptable calcium compounds include, without limitation, any of the well-known calcium supplements such as calcium carbonate, calcium phosphate, calcium citrate, calcium sulfate, calcium oxide, calcium hydroxide, calcium apatite, calcium citrate-maleate, calcium lactate, calcium levulinate and the like.
- calcium compounds selected from the group consisting of calcium carbonate, calcium sulfate, and mixtures thereof are employed.
- Useful pharmaceutically acceptable zinc compounds include, without limitation, zinc sulfate, zinc chloride, and zinc oxide, with zinc sulfate being preferred.
- the pharmaceutically acceptable iron compound may be chosen from any of the well-known iron II (ferrous) or iron III (ferric) supplements, such as ferrous fumarate, ferrous sulfate, carbonyl iron, ferrous glucomate, ferrous chloride, ferrous lactate, ferrous tartrate, ferrous succinate, ferrous glutamate, ferrous citrate, ferrous pyrophosphate, ferrous cholinisocitrate, ferrous carbonate, iron-sugarcarboxylate complexes and the like, without limitation.
- iron II ferrous
- iron III iron supplements
- the iron compound comprises a pharmaceutically acceptable iron compound contained in a pharmaceutically acceptable film forming material which permits release of the iron in the stomach of a woman administered the supplement.
- the iron may or may not be coated.
- Suitable coatings include, without limitation, any material known in the art for forming enteric, controlled release, or sustained release coatings, such as cellulose ethers including hydroxypropyl methylcellulose, methylcellulose, ethylcellulose, and carboxymethylcellulose; cellulose esters such as cellulose acetate, cellulose acetate phthalate, and cellulose nitrate; acrylate and methacrylate copolymers; and the like.
- the coated iron compound has been found to provide increased iron bioavailability by minimizing interaction between the iron compound and divalent cations such as calcium in the nutritional supplement. Release of the iron in the intestine also minimizes stomach upset. More preferably, the iron is in the coating and is released in the stomach.
- the multi-vitamin and mineral supplements of the invention may include additional nutritional components well-known in the art.
- the supplements may include elemental magnesium dosed in the form of one or more pharmaceutically acceptable magnesium compounds, without limitation, such as magnesium stearate, magnesium carbonate, magnesium oxide, magnesium hydroxide, and magnesium sulfate.
- Magnesium stearate is a preferred form of the compound.
- the formulations may also include vitamin C, from about 0.1 mg to about 1 mg of folic acid, from 1 mg to about 3 mg of copper, and from about 0.05 mg to about 0.25 mg of iodine.
- Other nutritional agents well-known in the art may be included as desired.
- the optional vitamin C and folic acid nutritional components are coated to provide controlled release of these agents.
- the techniques and materials discussed above that are utilized to coat iron are preferred.
- compositions include, without limitation, cupric oxide, cupric sulfate, or cupric gluconate, with cupric oxide being preferred.
- Preferred pharmaceutically acceptable iodine compounds include sodium or potassium iodide, with potassium iodide being most preferred.
- the vitamins in the formulation may be provided in any source, without limitation.
- the amounts shown for each vitamin and mineral indicate the actual vitamin and mineral amounts, in milligrams (mg), in the formulations regardless of source, except where otherwise indicated.
- Vitamin A may be provided in any source, such as a preformed vitamin A compound or a vitamin A precursor, or any combination thereof.
- the amount of vitamin A in the formulations is expressed as an International Unit (I.U.) which is a measure of vitamin activity. Therefore, the indicated amounts for vitamin A refer to any amount of any precursor or preformed vitamin A compound, from any source whatsoever, which would result in the indicated amount of vitamin A activity in the body.
- I.U. International Unit
- the nutritional supplements of the invention may be provided in any suitable dosage form known in the art, without limitation.
- the compositions may be incorporated into tablets, powders, granules, beads, chewable lozenges, capsules, liquids, or similar conventional dosage forms, using conventional equipment and techniques known in the art. Tablet dosage forms are preferred.
- the dosage form can be in the form of a bi-layer tablet composed of at least one extended-release layer and at least one immediaterelease layer.
- the bi-layer tablet can be coated for ease of administration or can be enteric coated to reduce any gastric irritation and the unpleasant “burping” produced by the vitamins and minerals.
- multi-particulate design of extended release and immediate-release components can be enteric coated and compressed into a tablet or filled into hard or soft gelatin capsules.
- the nutritional components are normally blended with conventional excipients such as binders, including gelatin, pregelatinized starch, and the like; lubricants, such as hydrogenated vegetable oil, stearic acid, and the like; diluents, such as lactose, mannose, and sucrose; disintegrants, such as carboxymethyl cellulose and sodium starch glycolate; suspending agents, such as povidone, polyvinyl alcohol and the like; absorbent, such as silicon dioxide; preservatives, such as methylparaben, propylparaben, and sodium benzoate; surfactants, such as sodium lauryl sulfate, polysorbate 80, and the like; and colorants, such as F.D. & C dyes and lakes.
- binders including gelatin, pregelatinized starch, and the like
- lubricants such as hydrogenated vegetable oil, stearic acid, and the like
- diluents such as lactose, mannose, and sucrose
- inert, pharmaceutically acceptable carriers can be used which are either solid or liquid.
- Solid form preparations include powders, tablets, dispersible granules, capsules, and cachets.
- a solid carrier can be one or more substances which may also act as diluents, flavoring agents, solubilizers, lubricants, suspending agents, binders or tablet disintegrating agents; it can also be encapsulating material.
- the carrier is a finely divided solid which is in admixture with the finely divided active compounds.
- the active compound is mixed with carrier having the necessary binding properties in suitable proportions and compacted in the shape and size desired.
- the powders and tablets preferably contain from 5 or 10 to about 90 percent of the active ingredient.
- Suitable solid carriers are magnesium carbonate, magnesium stearate, talc, sugar, lactose, pectin, dextrin, starch, gelatin, tragacanth, methylcellulose, sodium carboxymethylcellulose, a low melting wax, coca butter, and the like.
- the term “preparation” is intended to include the formulation of the active compounds with encapsulating material as carrier providing a capsule in which the active component (with or without other carriers) is surrounded by carrier, which is thus in association with it.
- cachets are included. Tablets, powders, cachets, and capsules can be used a solid dosage forms suitable for oral administration.
- Liquid form preparations include solutions, suspensions, and emulsions.
- water or water/propylene glycol solutions for parenteral injection may be used.
- Liquid preparations can also be formulated in solution in aqueous polyethylene glycol solution.
- Aqueous solutions suitable for oral use can be prepared by dissolving the active component in water and adding suitable colorants, flavors, stabilizing and thickening agents as desired.
- Aqueous suspensions suitable for oral use can be made by dispersing the finely divided active component in water with viscous material, i.e., natural or synthetic gums, resins, methylcellulose, sodium carboxymethylcellulose, and other well-known suspending agents.
- solid form preparations which are intended to be converted, shortly before use, to liquid form preparations for either oral or parenteral administration.
- liquid forms include solutions, suspensions, and emulsions.
- solid form preparations are most conveniently provided in unit dose form and as such are used to provide a single liquid dosage unit. Alternately, sufficient solid may be provided so that after conversion to liquid form, multiple individual liquid doses may be obtained by measuring predetermined volumes of the liquid form preparation as with a syringe, teaspoon, or other volumetric container. When multiple liquid doses are so prepared, it is preferred to maintain the unused portion of said liquid doses at low temperature (i.e., under refrigeration) in order to retard possible decomposition.
- the solid and liquid forms may contain, in addition to the active addition to the material, flavorants, colorants, stabilizers, buffers, artificial and natural sweeteners, dispersants, thickeners, solubilizing agents, and the like.
- the liquid utilized for preparing the liquid form preparation may be water, isotonic water, ethanol, glycerine, propylene glycol, and the like as well as mixtures thereof. Naturally, the liquid utilized will be chosen with regard to the route of administration, for example, liquid preparations containing large amounts of ethanol are not suitable for parenteral use.
- the preparations are in unit dosage form.
- the preparation is subdivided into unit doses containing appropriate quantities of the active components.
- the unit dosage form can be a packaged preparation, the package containing discrete quantities of preparation, for example, packeted tablets, capsules, and powders in vials or ampoules.
- the unit dosage form can also be a capsule, cachet, or tablet itself or it can be the appropriate number of any of these in packaged form.
- the quantity of active compound in a unit dose of preparation may be varied according to the particular application and the potency of the active ingredients.
- the total daily dosage may be divided and administered in portions during the day if desired or at one time, morning, afternoon, or night as well as biphasic, triphasic, etc.
- the portion administered in one dose during a day need not be equal to all or any other doses administered during a day.
- the total daily dosage is divided into two different doses, such as an AM and a PM dose
- one vitamin such as vitamin B 6
- one vitamin such as vitamin B 6
- the vitamins and/or minerals may be treated in such a manner.
- the amount of a vitamin and mineral in each dose is determined as the amount which will achieve optimal or maximal efficacy with minimal side effects.
- the use of such unequal doses during the course of a day may apply to the entire formulation, or any individual vitamin or mineral in said formulation.
- it is believed that the use of unequal doses increases the bioavailability of some or all of the nutrients provided in the formulations.
- Controlled and uncontrolled release formulations as well as sustained release, extended release, timed release, delayed release and other such formulations, without limitation, are contemplated for use with the present invention.
- the products of the invention are preferably intended for administration to humans, it will be understood that the formulation may also be utilized in veterinary therapies for other animals.
- compositions were used to prepare multi-vitamin and mineral supplements for administration to lactating, non-lactating, and menopausal women:
- Tablets incorporating the above formulations were prepared using conventional methods and materials known in the pharmaceutical art. The resulting nutritional supplement tablets were recovered and stored for future use.
- compositions were used to prepare multi-vitamin and mineral supplements for administration to lactating, non-lactating and menopausal women.
Abstract
Description
TABLE I | |||
Component | Lactating | Non-Lactating | Menopausal |
Calcium, mg | 320-480 | 160-240 | 320-480 |
Vitamin D, I.U. | 400-600 | 320-480 | 320-480 |
Vitamin B12, mg | 0.006-0.015 | 0.006-0.040 | 0.020-0.030 |
Vitamin B6, mg | 8-40 | 8-40 | 8-40 |
Vitamin B3, mg | 18-30 | 15-30 | 10-40 |
Vitamin B2, mg | 2.7-5.0 | 2.7-5.0 | 2.7-5.0 |
Vitamin B1, mg | 3.2-4.8 | 2.6-4.8 | 1-3 |
Vitamin E, I.U. | 20-40 | 24-100 | 70-110 |
Iron, mg | 28-43 | 6-42 | 7-11 |
Zinc, mg | 20-30 | 12-30 | 10-30 |
Vitamin C, mg | 60-300 | 60-300 | 60-300 |
Molybdenum, mg | 0.020-0.030 | 0.040-0.060 | 0.040-0.060 |
Chromium, mg | 0.040-0.060 | 0.080-0.120 | 0.080-0.120 |
Vitamin A, I.U. | 2,000-10,000 | 2,000-10,000 | 2,000-10,000 |
Potassium, mg. | 40-60 | 40-60 | 64-96 |
Pantothenic | 12-18 | 8-12 | 8-12 |
Acid, mg | |||
Folic Acid, mg | 0.8-1.2 | 0.8-1.2 | 0.8-1.2 |
Biotin, mcg | 0.040-0.060 | 0.240-0.360 | 0.240-0.360 |
Copper, mg | 1.6-2.4 | 1.6-2.4 | 1.6-2.4 |
Iodine, mg | 0.120-.180 | 0.120-0.180 | 0.120-0.180 |
Magnesium, mg | 160-240 | 160-240 | 160-240 |
TABLE II | |||
Component | Lactating | Non-Lactating | Menopausal |
Calcium, mg | 400 | 200 | 400 |
Vitamin D, I.U. | 500 | 400 | 400 |
Vitamin B12, mg | 0.012 | 0.020 | .025 |
Vitamin B6, mg | 10 | 20 | 3 |
Vitamin B3, mg | 25 | 20 | 20 |
Vitamin B2, mg | 3.4 | 3.4 | 1.7 |
Vitamin B1, mg | 4.0 | 3.0 | 1.5 |
Vitamin E, I.U. | 30 | 75 | 90 |
Iron, mg | 36 | 18 | 9 |
Zinc, mg | 25 | 15 | 20 |
Vitamin C, mg | 120 | 200 | 240 |
Potassium, mg | — | 25 | 80 |
Pantothenic Acid, mg | 15 | 10 | 10 |
Folic Acid, mg | 1.0 | 1.0 | 0.5 |
Biotin, mg | 0.050 | 0.03 | 0.300 |
Copper, mg | 2 | 2 | 2 |
Iodide, mg | 0.150 | 0.150 | 0.150 |
Magnesium, mg | 200 | 200 | 200 |
Claims (14)
Priority Applications (3)
Application Number | Priority Date | Filing Date | Title |
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US09/448,744 US6488956B1 (en) | 1994-06-20 | 1999-11-24 | Multi-vitamin and mineral supplements for women |
US10/207,968 US20020187205A1 (en) | 1994-06-20 | 2002-07-31 | Multi-vitamin and mineral supplements for women |
US10/308,051 US20030068372A1 (en) | 1994-06-20 | 2002-12-03 | Nutritional composition |
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US26251594A | 1994-06-20 | 1994-06-20 | |
US08/474,071 US5869084A (en) | 1994-06-20 | 1995-06-07 | Multi-vitamin and mineral supplements for women |
US12846698A | 1998-08-04 | 1998-08-04 | |
US09/448,744 US6488956B1 (en) | 1994-06-20 | 1999-11-24 | Multi-vitamin and mineral supplements for women |
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US12846698A Continuation | 1994-06-20 | 1998-08-04 |
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US10/207,968 Continuation US20020187205A1 (en) | 1994-06-20 | 2002-07-31 | Multi-vitamin and mineral supplements for women |
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US09/448,744 Expired - Fee Related US6488956B1 (en) | 1994-06-20 | 1999-11-24 | Multi-vitamin and mineral supplements for women |
US10/207,968 Abandoned US20020187205A1 (en) | 1994-06-20 | 2002-07-31 | Multi-vitamin and mineral supplements for women |
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